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WEDNESDAY, Nov. 1, 2023 (HealthDay News) — A new gene therapy for sickle cell disease was deemed safe by a U.S. Food and Drug Administration advisory panel on Tuesday, paving the way for full approval by early December. The FDA had already decided that the therapy, known as exa-cel, was effective. Developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland, exa-cel frees patients from the excruciating symptoms of sickle cell disease. If approved by Dec. 8, as expected, it would become the first medicine to treat a genetic disease with the CRISPR gene-editing technique, CRISPR Therapeutics said in a news release. But it won’t be the only new treatment for the inherited condition coming down the pike: By Dec. 20, the FDA will also decide on a second potential cure for a disease that typically strikes Black people, a gene therapy crafted by Bluebird Bio, of Somerville, Mass. “We are finally at a spot where we can envision broadly available cures for sickle cell disease,” said Dr. John Tisdale, director of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute and a member of the advisory committee, the New York Times reported. In the case of exa-cel, the one-time treatment permanently changes DNA in a patient’s blood cells. How does it work? Stem cells are removed from a patient’s… read on > read on >

Adding warning labels to meat about its impact on climate and health could lower its consumption, a new study suggests. British researchers investigated what adding cigarette-style graphic warning labels to meat in a cafeteria setting might do. “Reaching net zero is a priority for the nation and the planet. As warning labels have already been shown to reduce smoking as well as drinking of sugary drinks and alcohol, using a warning label on meat-containing products could help us achieve this if introduced as national policy,” said study author Jack Hughes. Hughes conducted the research with his supervisors as part of his PhD program in the department of psychology at Durham University, in the United Kingdom. The study included a representative sample of just over 1,000 meat-eating adults who were split into four groups. They were shown pictures of hot meals a person might get at a cafeteria that contained a health warning label, climate warning label, pandemic warning label, or no label. An example set of meals could be a meat pasta bake, fish pasta bake, vegetarian pasta bake and a vegan pasta bake, the study authors noted. Participants were asked to make 20 separate decisions on different meal choices. They were also asked how anxiety provoking and believable they found the labels. The researchers measured future intentions to buy and eat the meal options,… read on > read on >

TUESDAY, Oct. 31, 2023 (HealthDay News) – Certain pureed fruit pouches from WanaBana may contain dangerous levels of lead, the U.S. Food and Drug Administration has warned. Parents and caregivers should not buy or serve WanaBana apple cinnamon fruit puree pouches to children, the agency said in a recent public health alert. Children who have consumed this product should be tested for possible lead poisoning, the agency added. The warning was issued after four children in North Carolina were found to have high levels of lead in their blood that was linked to these products, the FDA said. State health officials detected “extremely high” concentrations of lead in the pouches after analyzing multiple lots. This exposure could lead to “acute toxicity,” according to the FDA. Lead can enter food products through soil, air, water and industrial processes, according to the American Academy of Pediatrics. It’s not good for anyone, but can seriously harm children’s health. Lead can cause brain and nervous system damage, as well as slowed growth and development. WanaBana is based in Coral Gables, Fla. The company has issued a recall for all lot codes and expiration dates of the products, which are sold nationally. Among the places that carry these products are Amazon, Dollar Tree and Sam’s Club. More information The U.S. Centers for Disease Control and Prevention has more on the… read on > read on >

The ancient art of tai chi, plus a modern twist, may help older adults reverse mild declines in brain power, a new clinical trial reveals. Researchers found that tai chi classes helped older adults improve their subtle problems with cognition (memory and thinking skills). It also helped them with a fundamental multitasking skill: walking while your attention is elsewhere. But while tai chi was effective, a “cognitively enhanced” version that added mental challenges to the mix worked even better, the study found. Experts called the findings — published Oct. 31 in the Annals of Internal Medicine — promising. They support the concept of stimulating seniors’ minds in multiple ways, rather than one. Tai chi is a traditional Chinese practice that combines slow, graceful movement and physical postures with controlled breathing. It’s performed as a moving meditation, and studies over the years have found that it can help older people improve their balance and lower their risk of falls. There is also evidence that tai chi can help seniors sharpen their cognition, said Peter Harmer, a researcher on the new trial. His team wanted to test the effects of adding specific mental challenges to the tai chi practice — based on recent studies suggesting that physical and mental exercise together are better than either alone. Conventional tai chi classes, like most physical exercise classes, are primarily… read on > read on >

Working out offers a lot of health benefits, and the risks are astonishingly small, according to a new study from the United Kingdom. “This work demonstrates that engaging in fitness activities is overwhelmingly a safe and beneficial pursuit,” said study co-author Dr. Sean Williams, a researcher at the University of Bath Center for Health and Injury and Illness Prevention in Sport. “While no physical activity is entirely without risk, the chance of serious injury is exceedingly low when compared to the myriad health and wellness advantages gained from staying active,” Williams continued in a university news release. The five-year study found that even forms of exercise sometimes considered risky by the public, such as road cycling, are generally safe. Data for the study came from hospitals in England and Wales. The researchers found that between 2012 and 2017, nearly 12,000 trauma injuries resulted from sports and exercise. The study looked at 61 sports and other physical activities to provide a comparable estimate of the risks to participants. Running, golf, dance classes and gym sessions were the least likely to result in injury. Running had in 0.70 injuries, golf 1.25 injuries and fitness classes just 0.10 per 100,000 participants a year. Among the most popular sports, soccer had the highest injury incidence rate at 6.56 injuries per 100,000 participants a year. The authors characterized this as… read on > read on >

Taking the drug metformin – typically used for type 2 diabetes – can help counter weight gain in young people who are taking medication for bipolar disorder, according to a new trial. While second-generation antipsychotic medications (SGAs) that treat bipolar disorder can help improve mental health, significant side effects include higher blood pressure and blood sugar, increased appetite and weight gain. “We, the clinicians, naively justified that we’re improving your psychosis, so just deal with the weight gain,” said trial co-leader Dr. Victor Fornari, a child/adolescent psychiatrist at Northwell Health in Glen Oaks, N.Y. “But patients stopped taking their medicine because they said they didn’t want to gain weight.” A survey showed patients wanted interventions to reduce these side effects, according to Christina Klein, a University of Cincinnati research scientist. The study had broad enrollment criteria and was conducted at a wide variety of clinics, she said. It included more than 1,500 patients ages 8 to 19 who had bipolar disorder and were taking SGAs. “It was a large sample of patients to really demonstrate what’s going on,” Fornari said in a University of Cincinnati news release. “I don’t know that anybody has done a study of this magnitude.” Trial participants received recommendations for healthy eating and exercise. Half were also prescribed metformin. “If patients weren’t doing well on the metformin, they could come off… read on > read on >

Experts have long wondered whether diagnoses for attention deficit hyperactivity disorder (ADHD) in the youngest children in a class would hold. A new study suggests that being the youngest, and possibly most immature, did not appear to make a difference. “We know the youngest children in their year group are more likely to be diagnosed with ADHD — but many believe this is because they lag behind their older classmates,” explained senior study author Dr. Samuele Cortese, a child and adolescent psychiatrist at the University of Southampton in the United Kingdom. “However, no one has ever explored if these younger children who are diagnosed with ADHD retain the diagnosis later on — until now,” Cortese said in a university news release. “Our study shows for the first time that these youngsters are no more likely to lose the diagnosis over time than older children.” More than 360 million people worldwide have been diagnosed with ADHD, according to the World Health Organization. About one-third are children and adolescents. Symptoms include impulsiveness, disorganization, poor time management skills, difficulty focusing and restlessness. This new study was led by researchers from University of Southampton and Paris Nanterre University, who collaborated with 161 scientists from around the world. They used data from more than 6,500 patients who had ADHD, who were followed for a period between the ages of 4… read on > read on >

Time-restricted dieting may be a better way for people with type 2 diabetes to lose weight than counting calories, a new study suggests. Researchers found that people who only ate between noon and 8 p.m. each day lost more weight than those who reduced their calories by 25%. Both groups, however, had similar reductions in long-term blood sugar levels based on a test of hemoglobin A1C. The test shows blood sugar levels over the past three months. “It’s important to give people with type 2 diabetes more than one strategy to lose weight and decrease their HbA1C,” said lead researcher Krista Varady, a professor of nutrition at the University of Illinois, Chicago. “Some people find it difficult to count calories. Others don’t have weekly or monthly support and they need a dietary pattern that is simple to follow, such as watching the clock,” Varady added. In the United States, about 1 in 10 U.S. residents has diabetes, and that number is rising, the researchers said. It’s crucial to find more ways to control weight and blood sugar levels for these patients. While the study represents a “proof of concept” showing that time-restricted eating is safe for those with type 2 diabetes, Varady said people with diabetes should consult their doctor before starting this sort of diet. Also, “some medications for type 2 diabetes will lower… read on > read on >

Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant. Twenty-six eye care products are part of the alert. Contaminated products have the potential to cause eye infection and blindness because drugs applied to the eye can bypass some of the body’s defenses. Those concerning the U.S. Food and Drug Administration are branded CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up and Velocity Pharma. The FDA urged the manufacturer to recall all lots of these products. CVS, Rite Aid and Target are pulling products from shelves and websites. Although there were no reports of infection, bacterial tests were positive in critical drug product areas of the plant. The FDA’s list of eye products to avoid is here. Patients and providers should report any issues to the FDA. Consumers should discard products involved in the recall at a drug take-back site. They can also check the FDA’s flush list to see if they can be safely discarded at home, the New York Times reported. Certain products — those branded Leader, Rugby and Velocity — may still be available for purchase in stores and online. Don’t buy them, the FDA advised. Rite Aid is removing “applicable Rite Aid branded products” from store shelves, a spokeswoman said. CVS “immediately… read on > read on >

MONDAY, Oct. 30, 2023 (HealthDay News) — Patients with sickle cell disease may soon have two new treatments to try. On Tuesday, a U.S. Food and Drug Administration advisory committee will weigh the merits of a new gene therapy for the painful, inherited condition, which typically strikes Black people. The agency is expected to make a decision on that therapy in early December, and it also plans to decide on a second new treatment before year’s end, the Associated Press reported. The treatment being reviewed Tuesday is based on CRISPR technology, a gene-editing tool. The inventors of that tool won the Nobel Prize in 2020 for their work, the AP reported. A one-time treatment, “exa-cel” is made by Vertex Pharmaceuticals and CRISPR Therapeutics, and it permanently changes DNA in a patient’s blood cells. How does it work? Stem cells are removed from a patient’s blood, and then CRISPR knocks out a gene that triggers the development of defective, crescent-shaped blood cells. Meanwhile, medicine kills off flawed blood-producing cells in patients, who are then given back their own altered stem cells. “Anything that can help relieve somebody with this condition of the pain and the multiple health complications is amazing,” Dr. Allison King, a professor at Washington University School of Medicine in St. Louis, told the AP. “It’s horribly painful. Some people will say it’s like being stabbed… read on > read on >

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FDA Advisors Say New Gene Therapy for Sickle Cell Disease is Safe

Does Meat Need Warning Labels on How It Harms Climate, Health?

FDA Warns WananBana Fruit Puree Pouches May Contain Lead

Tai Chi Might Help Seniors Counter Mild Cognitive Decline

Get Active: Study Finds Most Forms of Exercise Are Very Safe

Metformin May Help Young Patients With Bipolar Disorder Avoid Weight Gain

Youngest Kids With ADHD in Class No Less Likely to See Diagnosis Fade

Fasting Diets Beat Low-Cal Regimens for Folks With Diabetes

FDA Warns Eyedrops From Major Brands May Cause Infection

FDA Advisors to Weigh New Gene Therapy for Sickle Cell Anemia